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Post Market Clinical Follow-Up Study - Medical Device KalobaNaso

NCT05960318 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 131

Last updated 2023-09-07

No results posted yet for this study

Summary

The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaNaso (a nasal spray) in children, adolescents and adults with common cold symptoms, such as runny nose, nasal congestion and rhinitis. The main questions it aims to answer are:

* Is the product effective in the treatment of common cold symptoms?
* Is the product safe?

After buying the product, participants will be asked to fill in a questionnaire, in order to:

1. Assess the cold symptoms before the use of the nasal spray.
2. Assess the resolution of cold symptoms after the use of the nasal spray.
3. Describe the adverse effect(s)/problem(s) observed while using the product (if any).

Conditions

  • Common Cold
  • Nasal Mucosal Inflammation
  • Rhinitis

Interventions

DEVICE

KalobaNaso spray

Nasal spray, 2 puff per nostril, 3 times a day

DEVICE

KalobaNaso junior spray

Nasal spray, 1 puff per nostril, 3 times a day

Sponsors & Collaborators

  • Schwabe Pharma Italia

    lead INDUSTRY

Principal Investigators

  • Floriana Raso · Schwabe Pharma Italia

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960318 on ClinicalTrials.gov